Ledade Samir D, Jain Shishir N, Darji Ankit A, Gupta Vinodkumar H
Department of Medical Writing, Tata Consultancy Services, Mumbai, Maharashtra, India.
Perspect Clin Res. 2017 Apr-Jun;8(2):58-62. doi: 10.4103/2229-3485.203044.
A narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial. Narrative writing involves multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required. A sponsor outsources narrative writing activities to leverage the expertise of service providers which in turn requires effective management of resources, cost, time, quality, and overall project management. Narratives are included as an appendix to the clinical study report and are submitted to the regulatory authorities as a part of dossier. Narratives aid in the evaluation of the safety profile of the investigational drug under study. To deliver high-quality narratives within the specified timeframe to the sponsor can be achieved by standardizing processes, increasing efficiency, optimizing working capacity, implementing automation, and reducing cost. This paper focuses on effective ways to design narrative writing process and suggested best practices, which enable timely delivery of high-quality narratives to fulfill the regulatory requirement.
病例描述是对患者在临床试验过程中所经历的特定事件的简要总结。病例描述撰写涉及多项活动，如生成患者档案、审查数据来源以及确定需要撰写病例描述的事件。申办方将病例描述撰写活动外包，以利用服务提供商的专业知识，这反过来需要对资源、成本、时间、质量和整体项目管理进行有效管理。病例描述作为临床研究报告的附录包含在内，并作为档案的一部分提交给监管机构。病例描述有助于评估所研究的试验药物的安全性概况。通过标准化流程、提高效率、优化工作能力、实施自动化和降低成本，可以在规定时间内为申办方提供高质量的病例描述。本文重点介绍设计病例描述撰写流程的有效方法和建议的最佳实践，以确保及时提供高质量的病例描述，满足监管要求。
